Experimental Research on Deep Carious Lesion Treatment of Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2020-10-04

Brief Summary

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Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. These are the first molars (FPM), which are frequently affected by caries, soon after their eruption.

In the present application, our main goal is to determine whether two treatment groups (MTA and TheraCal) are long-term effective in preserving pulp vitality among children' FPM affected by deep caries.

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Detailed Description

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Among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous.

MTA proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time.

TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TheraCal

Indirect pulp capping with TheraCal

Group Type EXPERIMENTAL

TheraCal

Intervention Type OTHER

Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal

Mineral trioxide aggregate (MTA)

Indirect pulp capping with MTA

Group Type ACTIVE_COMPARATOR

MTA

Intervention Type OTHER

Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA

Interventions

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TheraCal

Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal

Intervention Type OTHER

MTA

Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* untreated deep uncomplicated carious lesions in first permanent molars (FPM)
* absence of clinical diagnosis of pulp exposure
* fistula
* swelling of periodontal tissues
* abnormal tooth mobility
* history of spontaneous pain or sensitivity to percussion
* healthy appearance of adjacent gingiva
* normal tooth color
* positive vitality to thermal and electric tests.

Exclusion Criteria

* FPM with previous treatment
* FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
* children with mental disabilities or systemic diseases.

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No